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The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
The FDA has established a public docket so that compounding pharmacies and others can share their experiences and views regarding the agencies drug compounding regulations. Read More
Astellas Pharma will launch its antifungal drug Cresemba in the coming months, following FDA approval for adults with invasive aspergillosis and invasive mucormycosis — rare, but serious fungal infections most often seen in patients with compromised immune systems. Read More
CorePharma will divest generic rights to a dry mouth therapy and a liver drug to clear the way for Impax’s $700 million acquisition of the Middlesex, N.J., drugmaker. Read More
Sun Pharmaceuticals is recalling 5,322 bottles of Ketorolac tromethamine ophthalmic solution in the U.S. and Puerto Rico for failing to meet specifications. Read More
Bristol-Myers Squibb and Pfizer’s Eliquis won a positive nod in the UK, with the National Institute for Health and Care Excellence deeming it clinically effective and cost-effective in treating and preventing blood clots in the lungs, pelvis, legs or arms. Read More
Gilead Sciences has ratcheted up efforts to get the Supreme Court to hear a double patenting lawsuit, arguing the Federal Circuit’s ruling invalidating patent protection for its influenza drug Tamiflu effectively rewrites the obviousness-type double patenting doctrine. Read More
Particulate contamination and a labeling error prompted Hospira to recall single lots of two injectable drugs, 0.9 percent sodium chloride injection and magnesium sulfate injection in 5 percent dextrose. Read More
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure that data is stored securely, the FDA says in Friday draft guidance on handling electronic informed consents. Read More
China is opening its market to biosimilars, issuing the country’s first-ever guideline on the technical review of the products and criteria for establishing biosimilarity. Read More
The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More